To investigate the effect of banded sleeve gastrectomy
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight loss: Total body weight loss after 3 years
Secondary outcome
Weight loss: Excess weight loss, Excess Body Mass Index loss
Complications and reoperations
Reduction of comorbidities: tyhpe 2 diabetes, hypertension, hypercholesteromie,
jointcomplaints, OSAS
Quality of life: BARS, SF36 and Body Q
Reflux: GERD-HRQL
f- Food tolerance: F1.10 Quality of Alimentation + additional food groups op 3
and 5 jyears postoperatively
Background summary
Last decennium the sleeve gastrectomy gained popularity as primary procedure.
Despite good short term results, a significant number of sleeve patients regain
weight after an initial good result. The cause of weight regain is
multifactorial. Dilatation of sleeve is often described as the main cause.
Placement of ring around the pouch could prevent dilatation and therefore
weight regain.
Study objective
To investigate the effect of banded sleeve gastrectomy
Study design
A prospective, multicenter, randomized controlled trial
Intervention
Banded sleeve gastrectomy
Study burden and risks
- More dysfagia
- More reflux complaints
- Removal of the ring
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
- Age between and 65 years
- BMI > 40 kg/m2
- BMI > 35 kg/m2 with comorbidities of which expect to improve after surgery
- Medical history of overweight for at least 5 years
- Proven failed attempts to lose weight in a conservative way, or initial good
result with relapse
- The intention to fully follow the postoperative program
Exclusion criteria
- Mental disorder, psychotic disorder, severe depression and personality
disorder
- Never had professional medical guidance with weight loss
- Not able to participate in long-term medical checks
- Alcohol or drug abuse
- Diseases that form a threat on life expectancy on the short term
perioperavtively
- Patients who can not taken care for themselfs, or patients who do not have
any social network to take this responsibility
- Pregnacy
- BMI > 60 kg/m2 and/or a planned 'two stage' treatment with a SADI procedure
- Bariatric surgery in the medical history
- Patients with a language barrier which can have affect on medical follow-up
and treatment
- Patients with a disease not related to morbid obesity, e.g. Cushing or
medication related
- Chronic bowel diseases, e.g. M. Crohn, colitis ulcerosa
- Renal impairment (MDRD<30) of hepatic dysfunction (ASAT/ALAT twice the normal
value)
- Patients with therapy resistant reflux symptoms, defined as persistant
symptoms despite the use of maximum dose proton-pump-inhibitors (pantozol
2dd40mg/omeprazol 2dd40mg)
- Genetic cause of obesity
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70754.091.19 |